Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
Information source: Ewha Womans University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Bupropion, Escitalopram (Drug); Escitalopram (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ewha Womans University Official(s) and/or principal investigator(s): In Kyoon Lyoo, MD, PhD, MMS, Principal Investigator, Affiliation: Ehwa W. univ hospital
Summary
The current study is being conducted in patients with major depression. The study aims to 1)
investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and
bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue,
hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes
using magnetic resonance imaging (MRI), 3) and examine a relationship between the
improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.
Clinical Details
Official title: Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Change from Baseline in Depressive Symptom Scores at 8 WeeksChange from Baseline in Depressive Symptom Scores at 4 Weeks Change from Baseline in Depressive Symptom Scores at 1 Week
Secondary outcome: Number of Participants with Adverse EventsChange from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach Number of Participants with Adverse Events Number of Participants with Adverse Events Changes in Fatigue Severity Scale scores
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men and women aged between 20 and 65
- Diagnosis of major depressive disorder (MDD) as assessed by the Structured Clinical
Interview for DSM-IV (SCID-IV)
- Individuals who provided written consent for participation.
Exclusion Criteria:
- Presence of any major physical or neurological illness (e. g., head trauma, epilepsy,
seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease,
narrow-angle glaucoma, drug hypersensitivity, etc.)
- Diagnosis of any Axis I disorder other than MDD or presence of symptoms requiring
hospitalization
- Intelligence quotient (IQ) below 80
- Contraindications to magnetic resonance imaging (e. g., pacemaker implantation,
claustrophobia, etc.)
- Unstable medical illness or other abnormalities observed at the screening or
laboratory tests
- Women who are pregnant, breastfeeding, or planning pregnancy
- Allergy or tolerance to the clinical trial medication
- Presence of any physical illness that contraindicates the clinical trial medication
(e. g., epilepsy, history of uncontrollable narrow-angle glaucoma)
- Use of psychoactive medications that may affect brain imaging findings
Locations and Contacts
Seoul National University Hospital, Biomedical Research Institute, Seoul 110-744, Korea, Republic of
Additional Information
Starting date: March 2009
Last updated: April 9, 2014
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